Intra-uterine contraceptive device



Aug. 20, 1968 G. MAJZLIN 3,397,690

INTRA-UTERINE CONTRACEPTIVE DEVICE Filed Dec. 1, 1965 2 Sheets-Sheet 1F/aa' INVENTOR. GREGORY MAJZLIN A r ran/vars 0, 1968 G. MAJZLIN3,397,690

INTRA-UTERINE CONTRACEPTIVE DEVICE Filed Dec. 1, 1965 2 Sheets-Sheet 2INVEN R. GREGORY MAJZ BY 9, wmxzm A 7' TORNEYS United States Patent3,397,690 INTRA-UTERINE CONTRACEPTIVE DEVICE Gregory Maizlin, 92 WhitmanDrive,

Brooklyn, N.Y. 11234 Filed Dec. 1, 1965, Ser. No. 510,752 9 Claims. (Cl.128-130) ABSTRACT OF THE DISCLOSURE An intra-uterine device is providedfor placement within the uterus to prevent conception and to obtainsamples of uterine wall tissue. The device is made from a flexiblematerial and has at least two arms connected together by a connectingmember, said connecting member having at least one pivot point locatedbetween the arms at a-point above the level of the bottom edge of thearms and below the level of the top edge of the arms.

This invention relates to an improved intra-uterine contraceptive deviceand more particularly to an intrauterine contraceptive device whichutilizes the muscular contractions of the uterus to firmly retain thedevice in place. The device is self-adjusting to fit variations of theuterine cavity.

It is well known that foreign bodies introduced into the uterus willprevent pregnancy. Although there are a number of intra-uterinecontraceptive devices now being used, these have not achieved wideacceptance due to the tendency of the device to be expelled from theuterus. The expulsion of the intra-uterine contraceptive device startswith the muscular contraction which takes place when the device isintroduced in the uterus cavity. Thereafter the muscles ofthe uteruswork to expel the foreign body and as frequently happens the expulsionis not noticed by the user.

In accordance with the present invention, there has now been devised anintra-uterine contraceptive device with a structure especially adaptedto take advantage of the uterine muscular contractions which work tofirmly retain the device in place and guard against expulsion from theuterus. For this purpose there has been devised a device which comprisesa flexible member having at least two arms so constructed that the lowerend portions thereof are spaced apart and separated. The arms areflexibly coupled by means of a connecting member in such a way that whenpressure is brought to bear against the top portion of the arms theywill pivot inwardly and cause the lower portion of the arms to press outagainst the Walls of the uterus. As a result of the pressure of thelower portion of the arms outwardly against the walls of the uterus thedevice is firmly retained in place.

In order to understand the mechanism by which the device of the presentinvention is retained in the uterus, it is first necessary to understandthe way in which the uterine muscles work.

The uterus is a hollow walled muscular organ approximately 3 inches inlength. It consists of three main parts, the corpus, the cervix and theisthmus which is located at the junction of the cervix and corpus. Thecervix is at the bottom of the uterus and it is approximately one inchlong or one-third the entire length of the uterus. The isthmus which isthe next part is located above the cervix and is approximately /2 inchlong. The remaining 1 /2 inches of the uterus is called the corpus.

The uterine tubes through which the egg passes from the ovaries arelocated at opposite sides of the top portion of the corpus. The roof ofthe corpus positioned above the level of a line joining the points ofentrance of the uterine tubes is called the fundus.

The introduction of a contraceptive device into the 3,397,690 PatentedAug. 20, 1968 uterus causes muscular contraction. Muscular contractionoccurs in two sequential steps. The first muscular contraction occurs inthe cervico-isthmal region where the muscle fibers are arranged incircular fashion. This will cause the walls to approach each othersqueezing the contraceptive device located in that region. The secondmuscular contraction occurs at the fundus where the muscular fibers arearranged in a generally longitudinal direction. The general longitudinalarrangement of the muscular fibers results in a downward contractingforce which tends to cause expulsion of the contraceptive device out ofthe uterine cavity through the cervix.

When the device of the present invention is inserted into the uterinecavity it is so positioned that the lower portion of the arms arelocated in the lower portion of the uterus and the upper portion of thearms are located in the upper portion of the uterus or within the fundalarea. When in place in the uterus the muscular contractions of thecervico-isthmal region will begin and pressure will be exerted againstthe lower portion of the arms tending to force them together. The lowerportions of the flexible arms yield but resist the pressure, whichresults in a camming action that tends to move the entire device upwardtoward the fundus or top of the uterine cavity. After the muscles of thecervico-isthmal region relax the muscular fibers of the fundus willstart to contract. The contraction of the fundal muscles will exert apressure against the top portion of the arms bending them inwardly. Thiswill cause the arms to pivot about at least one point located betweenthe arms and below the level of the top edge of said arms on theconnecting member and thereby force the lower portion of the armsoutwa'rdly. At the same time, this pressure at the top of the devicewill tend to move the entire device downwardly towards thecervico-isthmal region. Since the lower portion of the arms are extendedoutwardly they press against the walls of the cervico-isthmal regionwhich results in firmly retaining the device in place. After the fundalmuscles relax contraction will again begin in the cervico-isthmal regionto repeat the above described process.

Another advantage of the structure of applicants device is the fact thatonly one or two sizes are required to fit nulliparous, monoparous andmultiparous women. In conventional intra-uterine contraceptive devicesmany sizes are required in order to properly fit a woman which is oftena time consuming process with the results often in doubt. Applicant byutilizing the contractions of the uterus to hold his device in placedoes not require the close tolerances necessary for the knownintra-uterine contraceptive devices to prevent the expulsion of thedevice from the uterus.

These and other features of the intra-uterine contraceptive device arebest understood by reference to the following drawings showing thepreferred embodiments of the invention in which:

FIG. 1 is one embodiment of the intra-uterus contraceptive device.

FIG. 2 is the intra-uterus contraceptive device of FIG. 1 in collapsedposition ready to be inserted into the uterus.

FIG. 3 illustrates the intra-uterine contraceptive device of FIG. 1 asit is inserted into the uterus. No muscular contraction is shown.

FIG. 4 illustrates the intra-uterine contraceptive device of FIG. 1 inthe uterus where the muscles of the fundus are contracted.

FIG. 5 is another embodiment of the intra-uterine contraceptive device;and

FIG. 6 is a third embodiment of the intra-uterine contraceptive device.

The intra-uterine contraceptive device 18 which is made of any plasticor metal flexible material not injurious to living tissue is shown inFIG. 1. The device consists of two arms 20 and 22 which are joined by aconnecting member 24 also made of a flexible material.

The contraceptive device 18 is inserted into the uterine cavity bybringing the arms 20 and 22 of the device together (see FIG. 2). Thedevice is then placed in a metal or plastic flexible cannula with aplunger (not shown) and inserted with the cannula into the uterus. Thecannula is a conventional insertion device and the device and its useare known in the art.

Referring to FIG. 4 the uterus is divided into three areas. The cervix12, the isthmus 14 and the corpus 16. Located at the roof of the corpus16 is the fundus 17. In accordance with existing methods after thecannula is inserted into the uterine cavity the plunger is pushedforward releasing the contraceptive device into the uterine cavity inthe position shown in FIG. 3. Since the device is of a flexible materialthe two arms will return to their normal position after being releasedfrom the cannula. An alternate and improved method for placing thedevice in the uterus is to move the tube or cannula down upon theplunger instead of moving the plunger into the cannula. This willprevent a sudden expansion of the device in the uterus which may bepainful. It will also properly position the device in the fundal area.

It is important to use a small diameter cannula in order tosubstantially eliminate any pain to the patient. Since the thickness ofthe device in its folded position will determine the diameter of thecannula, the arm 22 is preferably made shorter than arm 20 so they canoverlap each other as shown in FIG. 2. This reduces the thickness of thedevice and enables a doctor to use a thinner cannula.

After the device is inserted into the uterus, the uterine muscles willstart to contract at the cervico-isthmal region. This is shown by theforce arrows indicated at A of FIG. 3. The magnitude of the force isgreater at the cervicoisthmal region and decreases as the funda] regionis approached. The force of the contraction will act on the lowerportion of the arms 20 and 22 to push them inwardly. The arms inresisting this muscular pressure will serve to cam the device upwardlytoward the fundus into the position shown in FIG. 4.

After the muscles in the cervico-isthmal region relax the muscles of thefundus start to contract and exert a force in the direction shown by theforce arrows indicated at B of FIG. 4. The magnitude of the force isgreater at the fundus and decreases as the cervico-isthmal region isapproached. This force is applied against the connecting member 24 andas a result the central portion of the connecting member 24 is depressedinto the dotted line position as shown at 26 of FIG. 4.

When the back of the connecting member 24 is bent the arms 20 and 22move outwardly and further apart from each other. This movement isfurther accented by the force of the contracted fundus against thetopmost portions of the arms 20 and 22 as at 30 and 32 to cause the.arms to pivot about point 26 and move the lower portions 21 and 23 ofthe arms outwardly. In order for this to occur, it will be understoodthat the force applied against the upper portion of the arms must bedirected in an area above the horizontal line xx in FIG. 4 whichdelineates the bottom of the bend in member 24 that forms the pivotalpoint for the movement of the arms. If the force is below the line xxthe arms will move inwardly and this will result in the device beingexpelled from the uterus. As explained above the force exerted by themuscles of the fundus against the connecting member 24 will bend themember 24 downwardly so as to establish a pivot point on the member 24located between the arms and below the top edge of said arms. If themember 24 is not bent the force exerted by the muscles of the fundusagainst the arms will force the arms together and the device will bereadily expelled from the uterus. By using the fundal muscles to bendmember 24 no permanent bend in member 24-is'necessary: The device willalso move downwardly as a result of the contraction of the fundus andthe arms whichare now spread out beyond the normal position shown inFIG. 1 will push against the side wall of the uterus to firmly retainthe device in place. The outward pressure of the arms against theuterine wall tends to cam the device upwardly against the downwardpressure of the fundus and there is little if any chance of accidentalexpulsion.

After the fundus relaxes contraction will start again in thecervico-isthmal region thereby repeating the process described above. Ifdesired the connecting member 24 may be weakened by reducing itsthickness in the central portion thereof as shown at 28 in FIG. 1 or thecentral portion of the member may be permanently bent down to initiatebending by the muscles of the fundus into the position shown in dottedlines in FIG. 4.

In the preferred form of structure shown, the ends of the arms arecurved inwardly to present a' curved surface which prevents irritationto the uterine wall when the lower portion of the arms press outwardlyagainst the wall during contraction of the fundus.

To further aid in the contraceptive ability one or more arms may 'bepositioned to extend downwardly from the central portion of theconnecting member 24 as shown at 34 in FIG. 1. The added arms 34 reducethe available space in the uterine cavity to prevent the apposition ofthe uterine Walls and thereby further aid in the contraceptive effect ofthe device.

The device is readily removed from the uterus by a process of versionwhen conception is desired. For this purpose one end of the arm of thedevice is pulled through the uterine canal causing the device to rotateso as to allow the connecting member and other arm to pass through theuterine canal without compressing the arms together.

FIG. 5 is another embodiment of the device which operates in the samemanner as the device described above. As shown in this figure the arms36 and 38 have the general shape of a U when viewed from the side in thedirectionof the arrows at 39. In this modified form of structure theconnecting member for the arms is-a rivet 40 which permits the arms topivot about the single point of the rivet 40 located between the arms togive a reverse scissoring effect. That is when the top portion of thetwo arms 36 and 38 are brought together the bottom portion of the armsmove outwardly.

The device is inserted into the uterus by bringing both the top andbottom ends of the pair of arms together. The collapsed device isinserted into a cannula with plunger and then inserted into the uterus.The contraceptive device is then released in the uterine cavity by meansof the cannula plunger. The device, which is made of a flexiblematerial, will return to its normal shape of FIG. 5 after it is releasedfrom the cannula.

Once the device is in the uterus, contractions will begin in thecervico-isthmal region. The force exerted Will be against the lower endsof the arms 36 and 38 causing the arms to pivot about the rivet 40. Thiswill cause the upper portion of the arms to move further apart therebyforcing the device towards the fundus or the upper part of the uterus.When the cervico-isthmal region relaxes, the fundal muscle fibers willstart to contract. The contracted fundus will force the device in adownward direction in the cervico-isthmal region and will also causepressure to be exerted against the top portion of the arms 36 and 38.The pressure exerted against the upper portion of the arms will causethem to move inwardly and the reversed scissoring effect will cause thelower portion of the arms to move outwardly against the upper walls ofthe cervico-isthmal region resulting in firmly retaining the device inplace.

The device is readily removed from the uterus when conception is desiredby pressing the arms together in the same manner as when the device isinserted into the uterus.

FIG. 6 is another embodiment of the device which operates in the samemanner as the devices described hereinabove except the arms pivot abouttwo points as opposed to only one point. The device has the generalshape of an H as seen in FIG. 6. The arms 42 and 44 are coupled by theconnecting member 46. After the device is inserted into the uterus thecontraction of the muscles of the fundus will apply pressure against thetop portions of the arms 42 and 44 as at 48 and 50 causing them to moveinwardly resulting in the arms 42 and 44 to pivot about points 52 and 54which are located on the connecting member 46 and which abut the arms 42and 44. The pivoting of arms 42 and 44 is a reverse scissoring effectcausing the lower portion of the arms to move outwardly against thewalls of the cervico-isthmal region resulting in firmly retaining thedevice in place.

Although the devices shown in the present application are formed fromsolid leaf-like members it will be understood that solid cylindricalmembers or tubing can be used to construct the present device. Furtherthe device can be molded as an integral unit or fabricated in separatepieces and then assembled.

It will be clear from the foregoing description that the inventionprovides an intra-uterine contraceptive device which is retained in theuterus by means of the uterine contractions and it is intended to coverall changes and modifications of the preferred form of the structureherein chosen for the purpose of illustration which do not constitutedepartures from the spirit and scope of the invention.

I claim:

1. An intra-uterine device comprising a flexible member having at leasttwo arms, a connecting member which couples said arms together, saidconnecting member having at least one pivot point located between thearms at a point above the level of the bottom edge of the arms and belowthe level of the top edge of said arms whereby when the top portion ofthe arms is moved inwardly in the area above said pivot point the bottomportion of the arms will move outwardly away from each other, saidflexible member being adapted for use in a uterus.

2. The intra-uterine device of claim 1 wherein the flexible member hasthe general shape of an inverted U.

3. The intra-uterine device of claim 2 having at least one armpositioned to extend downwardly from the central region of saidconnecting member.

4. The intra-uterine device of claim 1 wherein the lower portion of saidarms are curved inwardly.

5. The intra-uterine device of claim 1 wherein the flexible member hasthe general shape of an H and said connecting member has two pivotpoints about which the arms can move.

6. The intra-uterine device of claim 1 wherein the flexible member hasthe general shape of an X.

7. An intra-uterine device comprising a flexible memher having two arms,a connecting member being bent downward in between the top portion ofsaid arms to form at least one pivot point located between the arms at apoint above the level of the bottom edge of the arms and below the levelof the top edge of said arms when the uterine muscles of the fundusapply pressure against said member to bend it downwardly whereby whenpressure is applied inwardly against the top portion of the arms to bendthem inwardly, the bottom portion of the arms below said pivot pointwill move outwardly.

8. The intra-uterine device of claim 7 wherein the flexible member hasthe general shape of an inverted U.

9. The intra-uterine device of claim 1, wherein the flexible member hasthe general shape of an M.

References Cited UNITED STATES PATENTS 2,122,579 7/1938 Meckstroth128-130 2,681,652 6/1954 Laxton 128-132 3,200,815 8/1965 Marguliesl28130 3,253,590 5/1966 Birnberg 128-130 ADELE M. EAGER, PrimaryExaminer.

